New Risk Management Requirements under the EU Medical Device Regulation Date: July 15, 2020 Time: 8:00 AM PT | 11:00 AM ET Duration: 60-minutes Registration : https://event.on24.com/eventRegistration/EventLobbyServlet?target=reg20.jsp&partnerref=MDDIevite&elq_mid=13591&elq_cid=45095&eventid=2441830&sessionid=1&key=E408A23BA76C3609BCFA3C272232FD87&regTag=1176144&sourcepage=register Sponsored by: Topics covered include: • Overview of the many Risk Management requirements in the EU MDR – Regulation (EU) 2017/745 • Why device manufacturers should pay special attention to language around benefit-risk analysis, evaluation of overall residual risk, and production and post-production activities • Overview of the ISO 14971:2019 changes and how these changes will affect the technical documentation throughout the medical device lifecycle. • How to incorporate the ISO 14971:2019 changes into your ISO 13485:2016 Quality Management System • Utilization of the new ISO TIR 24971:2020 Speakers: Kimberly A. Trautman, MS. Executive Vice President Medical Device International Services NSF Medical Devices Kimberly A. Trautman, MS. Executive Vice President Medical Device International Services NSF Medical Devices

Posted on by admin
View

New Risk Management Requirements under the EU Medical Device Regulation

Date: July 15, 2020
Time: 8:00 AM PT | 11:00 AM ET
Duration: 60-minutes

Registration : https://event.on24.com/eventRegistration/EventLobbyServlet?target=reg20.jsp&partnerref=MDDIevite&elq_mid=13591&elq_cid=45095&eventid=2441830&sessionid=1&key=E408A23BA76C3609BCFA3C272232FD87&regTag=1176144&sourcepage=register
Sponsored by:

Topics covered include:

  • Overview of the many Risk Management requirements in the EU MDR – Regulation (EU) 2017/745
  • Why device manufacturers should pay special attention to language around benefit-risk analysis, evaluation of overall residual risk, and production and post-production activities
  • Overview of the ISO 14971:2019 changes and how these changes will affect the technical documentation throughout the medical device lifecycle.
  • How to incorporate the ISO 14971:2019 changes into your ISO 13485:2016 Quality Management System
  • Utilization of the new ISO TIR 24971:2020

Speakers:

Kimberly A. Trautman, MS.
Executive Vice President Medical Device International Services
NSF Medical Devices

 

Kimberly A. Trautman, MS.
Executive Vice President Medical Device International Services
NSF Medical Devices

Event Information

Event Topic:
New Risk Management Requirements under the EU Medical Device Regulation Date: July 15, 2020 Time: 8:00 AM PT | 11:00 AM ET Duration: 60-minutes Registration : https://event.on24.com/eventRegistration/EventLobbyServlet?target=reg20.jsp&partnerref=MDDIevite&elq_mid=13591&elq_cid=45095&eventid=2441830&sessionid=1&key=E408A23BA76C3609BCFA3C272232FD87&regTag=1176144&sourcepage=register Sponsored by: Topics covered include: • Overview of the many Risk Management requirements in the EU MDR – Regulation (EU) 2017/745 • Why device manufacturers should pay special attention to language around benefit-risk analysis, evaluation of overall residual risk, and production and post-production activities • Overview of the ISO 14971:2019 changes and how these changes will affect the technical documentation throughout the medical device lifecycle. • How to incorporate the ISO 14971:2019 changes into your ISO 13485:2016 Quality Management System • Utilization of the new ISO TIR 24971:2020 Speakers: Kimberly A. Trautman, MS. Executive Vice President Medical Device International Services NSF Medical Devices Kimberly A. Trautman, MS. Executive Vice President Medical Device International Services NSF Medical Devices

Event Description:

Date/Time:
Date(s) - 07/15/20
8:00 am - 9:00 am

Event Location:
Other: Webinar- requires registration

Event Details

Event Type